Postoperative PainNCT07327957
Effects of Vibration and Breathing Exercises on Pain and Anxiety During Chest Tube Removal
A study testing Vibration and Breathing Exercises in people with Postoperative Pain and Anxiety, run by Gamze BULUT at 1 site in Turkey (Türkiye).
Trial summary
Removing a chest tube is a common procedure after chest surgery, but it can cause significant pain and anxiety for patients. Although medications can help reduce these symptoms, they may have side effects and are not always sufficient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Anxiety, Thoracic Drainage
- What is being tested?
- Vibration and Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age and older,
- Conscious, oriented, and cooperative (e.g., Glasgow Coma Score ≥ 13),
- Able to speak and understand Turkish,
- Having a chest tube and undergoing chest tube removal for the first time,
- Hemodynamically stable,
- Having not taken analgesic, sedative, or anxiolytic drugs at least 4 hours prior to the procedure,
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- Able to communicate and respond to pain assessment scales during the procedure,
- No severe hearing, visual, or communication impairment,
- No neurological or cognitive disease that could affect the assessment of cognitive functions,
- No history of psychiatric diagnosis or active psychiatric treatment,
- Patients who voluntarily participate in the study and provide written consent will be included.
Who cannot join
- Patients with past or current cognitive and psychological disorders,
- Those who have previously had chest tube insertion,
- Those who are mechanically ventilated (intubated),
- Those who have chronic pain and routinely use analgesics,
- Those who used analgesics immediately before chest tube removal,
- Those who did not volunteer to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vibration and Breathing Exercises Applied Before Chest Tube Removal on Pain and Anxiety: A Randomized Controlled Trial
Removing a chest tube is a common procedure after chest surgery, but it can cause significant pain and anxiety for patients. Although medications can help reduce these symptoms, they may have side effects and are not always sufficient. Therefore, simple and safe non-drug methods are increasingly used to improve patient comfort.
This randomized controlled study aims to examine the effects of vibration and breathing exercises applied before chest tube removal on patients' pain and anxiety levels. Adult patients with a chest tube will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving standard care. Pain and anxiety levels will be measured before the procedure and after chest tube removal using validated scales.
The findings of this study are expected to show whether vibration and breathing exercises are effective in reducing pain and anxiety during chest tube removal. If effective, these methods may offer nurses an easy, low-cost, and safe way to improve patient comfort and support evidence-based nursing care.
Read the detailed description
Chest tube removal is a necessary clinical procedure following thoracic surgery, but it is frequently associated with acute pain and heightened anxiety. These symptoms may negatively affect patient comfort, cooperation, and recovery. While pharmacological interventions are commonly used to manage procedure-related pain and anxiety, concerns regarding side effects and limited effectiveness have increased interest in non-pharmacological approaches within nursing care.
This randomized controlled study is designed to evaluate the effectiveness of vibration and breathing exercises applied prior to chest tube removal on pain and anxiety levels. Eligible adult patients hospitalized in a thoracic surgery unit and scheduled for chest tube removal will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving routine care. Randomization will be performed using a web-based randomization tool to ensure equal allocation.
In the vibration group, a portable vibration device will be applied to the area proximal to the chest tube insertion site for a standardized duration before the removal procedure. In the breathing exercise group, participants will be guided through structured breathing exercises designed to promote relaxation and diaphragmatic breathing. The control group will receive standard clinical care without any additional non-pharmacological intervention.
Pain intensity and anxiety levels will be assessed at two time points: prior to the chest tube removal procedure and shortly after the procedure. Validated measurement tools will be used to ensure reliability of the findings. Data will be analyzed to compare changes in pain and anxiety levels within and between groups.
The results of this study are expected to provide evidence regarding the use of vibration and breathing exercises as simple, safe, and cost-effective nursing interventions to reduce pain and anxiety associated with chest tube removal. These findings may contribute to the development of evidence-based, non-pharmacological strategies in clinical nursing practice.
- Conditions
- Postoperative Pain, Anxiety, Thoracic Drainage
- Being tested
- Vibration, Breathing Exercises
- Medical subject headings
- Pain, Postoperative, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrationOther
Vibration will be applied using a portable data device inserted for a standard duration, combined with chest tube placement. The procedure will be performed with the patient in a comfortable position.
Breathing ExercisesOther
The remaining patients will be given breathing exercises including slow, deep, diaphragmatic, and iced-lip breathing techniques. These exercises will be performed calmly and quietly by the researcher to promote relaxation. The combined intervention will continue in addition to routine clinical care until the procedures and chest tube removal expense are completed.
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Experimental | Participants in this group will receive a non-pharmacological intervention consisting of vibration before chest tube removal. Vibration will be applied proximal to the chest tube insertion site for a standard duration using a portable vibrating device. The interventions will be performed in addition to routine clinical care. Receives: Other: Vibration |
| Control Group (Standard Care) | No intervention | Participants in the control group will receive routine clinical care according to standard hospital protocols prior to chest tube removal. No additional non-pharmacological interventions, including vibration or breathing exercises, will be applied before the procedure. |
| Breathing Exercise Group | Experimental | Individuals in the breathing exercise group will be led through breathing exercises by the researcher in their room before the procedure begins. The exercise duration is approximately 8-10 minutes. The environment should be quiet, at room temperature, and well-ventilated during the exercises. The patient should be seated in a comfortable position, and the following steps will be followed. Receives: Other: Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain intensity associated with chest tube removal will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will self-report their pain level.
Measured: Assessed immediately before chest tube removal and 10 minutes after the procedure.
Secondary outcomes (1)
Anxiety Level
Anxiety levels will be measured using the State Anxiety Inventory (State-Trait Anxiety Inventory - State subscale), a validated self-report questionnaire designed to assess situational anxiety. Higher scores indicate higher levels of anxiety.
Measured: Assessed immediately before chest tube removal and 10 minutes after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start15 Jun 2026
- Primary completion15 Sep 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gamze BULUT
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University
- Responsible party
- Sponsor-investigator, Gamze BULUT, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327957
- Sponsor's protocol ID
- CTT-VIBREATH-RCT-ATAU-2025
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The data collected in this study include sensitive health information, and sharing IPD may pose a risk to participant confidentiality and privacy. In addition, the informed consent obtained from participants does not include permission for data sharing beyond the research team. Therefore, IPD will be used solely for the purposes of this study and related scientific
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vibration and Breathing Exercises Applied Before Chest Tube Removal on Pain and Anxiety: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07327957
- Acronym / sponsor ID
- CTT-VIBREATH-RCT-ATAU-2025
- Conditions
- Postoperative Pain, Anxiety, Thoracic Drainage
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gamze BULUTUniversity, hospital or other
- Collaborators
- Ataturk University
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Removing a chest tube is a common procedure after chest surgery, but it can cause significant pain and anxiety for patients. Although medications can help reduce these symptoms, they may have side effects and are not always sufficient. Therefore, simple and safe non-drug methods are increasingly used to improve patient comfort.
This randomized controlled study aims to examine the effects of vibration and breathing exercises applied before chest tube removal on patients' pain and anxiety levels. Adult patients with a chest tube will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving standard care. Pain and anxiety levels will be measured before the procedure and after chest tube removal using validated scales.
The findings of this study are expected to show whether vibration and breathing exercises are effective in reducing pain and anxiety during chest tube removal. If effective, these methods may offer nurses an easy, low-cost, and safe way to improve patient comfort and support evidence-based nursing care.
Detailed description
Chest tube removal is a necessary clinical procedure following thoracic surgery, but it is frequently associated with acute pain and heightened anxiety. These symptoms may negatively affect patient comfort, cooperation, and recovery. While pharmacological interventions are commonly used to manage procedure-related pain and anxiety, concerns regarding side effects and limited effectiveness have increased interest in non-pharmacological approaches within nursing care.
This randomized controlled study is designed to evaluate the effectiveness of vibration and breathing exercises applied prior to chest tube removal on pain and anxiety levels. Eligible adult patients hospitalized in a thoracic surgery unit and scheduled for chest tube removal will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving routine care. Randomization will be performed using a web-based randomization tool to ensure equal allocation.
In the vibration group, a portable vibration device will be applied to the area proximal to the chest tube insertion site for a standardized duration before the removal procedure. In the breathing exercise group, participants will be guided through structured breathing exercises designed to promote relaxation and diaphragmatic breathing. The control group will receive standard clinical care without any additional non-pharmacological intervention.
Pain intensity and anxiety levels will be assessed at two time points: prior to the chest tube removal procedure and shortly after the procedure. Validated measurement tools will be used to ensure reliability of the findings. Data will be analyzed to compare changes in pain and anxiety levels within and between groups.
The results of this study are expected to provide evidence regarding the use of vibration and breathing exercises as simple, safe, and cost-effective nursing interventions to reduce pain and anxiety associated with chest tube removal. These findings may contribute to the development of evidence-based, non-pharmacological strategies in clinical nursing practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vibration | Experimental | Other: VibrationParticipants in this group will receive a non-pharmacological intervention consisting of vibration before chest tube removal. Vibration will be applied proximal to the chest tube insertion site for a standard duration using a portable vibrating device. The interventions will be performed in addition to routine clinical care. |
| Control Group (Standard Care) | No intervention | –Participants in the control group will receive routine clinical care according to standard hospital protocols prior to chest tube removal. No additional non-pharmacological interventions, including vibration or breathing exercises, will be applied before the procedure. |
| Breathing Exercise Group | Experimental | Other: Breathing ExercisesIndividuals in the breathing exercise group will be led through breathing exercises by the researcher in their room before the procedure begins. The exercise duration is approximately 8-10 minutes. The environment should be quiet, at room temperature, and well-ventilated during the exercises. The patient should be seated in a comfortable position, and the following steps will be followed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 years of age and older,
- Conscious, oriented, and cooperative (e.g., Glasgow Coma Score ≥ 13),
- Able to speak and understand Turkish,
- Having a chest tube and undergoing chest tube removal for the first time,
- Hemodynamically stable,
Key exclusion criteria (6 listed)
- Patients with past or current cognitive and psychological disorders,
- Those who have previously had chest tube insertion,
- Those who are mechanically ventilated (intubated),
- Those who have chronic pain and routinely use analgesics,
- Those who used analgesics immediately before chest tube removal,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibrationVibration will be applied using a portable data device inserted for a standard duration, combined with chest tube placement. The procedure will be performed with the patient in a comfortable position. | Other | Vibration |
| Breathing ExercisesThe remaining patients will be given breathing exercises including slow, deep, diaphragmatic, and iced-lip breathing techniques. These exercises will be performed calmly and quietly by the researcher to promote relaxation. The combined intervention will continue in addition to routine clinical care until the procedures and chest tube removal expense are completed. | Other | Breathing Exercise Group |
Primary outcome
Pain Intensity
Time frame: Assessed immediately before chest tube removal and 10 minutes after the procedure.
Pain intensity associated with chest tube removal will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will self-report their pain level.
1 secondary outcome
Anxiety Level
Time frame: Assessed immediately before chest tube removal and 10 minutes after the procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The data collected in this study include sensitive health information, and sharing IPD may pose a risk to participant confidentiality and privacy. In addition, the informed consent obtained from participants does not include permission for data sharing beyond the research team. Therefore, IPD will be used solely for the purposes of this study and related scientific
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration and Breathing Exercises in people with Postoperative Pain and Anxiety, run by Gamze BULUT at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Assessed immediately before chest tube removal and 10 minutes after the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.